The present invention relates generally to medical devices, and more particularly, to medical devices for use by patients having surgically created stomas.
Numerous surgical procedures result in the creation of a stoma, or surgically created opening in the body. For example, patients who undergo a cystectomy, which is the surgical removal of the bladder, may have a stoma created, usually in the abdomen wall or navel, to allow the passage of urine to the outside of the body from an internal reservoir. In the context of surgical procedures, such as a cystectomy, the stoma, with its attached internal conduit, is typically made to have a diameter that is operable with or matches a standardized catheter diameter size, as the patient will need to insert such a catheter several times daily in order to void.
Surgically created stomas often shrink during the recovery period, making the insertion of devices such as catheters difficult and painful for the patient. Also, there is an increased risk of urinary tract infection if irritation occurs due to repeated insertions over and through contracted or swollen tissues. Indeed, the irritation may become so acute that bleeding may result.
Accordingly, there is a need in the art for a device for maintaining the diameter, and minimizing the shrinkage of surgically created stomas.
Generally, Applicant has invented a stoma dilator that addresses these needs in the art.
According to an aspect of the invention, a stoma dilator is disclosed comprising a base and an insert integrally formed with the base and extending therefrom. The insert is inserted into the stoma while the base remains exterior to and abuts the body tissue surrounding the stoma. The girth of the insert increases at the portion of the insert that corresponds to the stoma entry location so as to be of sufficient size to maintain the desired stoma diameter and thereby prevent shrinkage. According to an aspect of the invention, the base is formed so as to create suction pressure between the dilator and the portion of the body surrounding the stoma and thereby provide additional securing forces between the dilator and the stoma.
A stoma dilator in accordance with the invention may be inserted into a patient stoma overnight or any other period so as to maintain the size of the stoma.
Additional aspects of the invention are described in detail below.